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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210589
Company: FRESENIUS KABI USA

Products on NDA 210589

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMEGAVEN	FISH OIL TRIGLYCERIDES	5GM/50ML (0.1GM/ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes
OMEGAVEN	FISH OIL TRIGLYCERIDES	10GM/100ML (0.1GM/ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210589

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2018	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/0210589s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210589Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210589Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210589s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210589Orig1s003ltr.pdf
05/08/2020	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210589s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207648Orig1s003, 210589Orig1s001ltr.pdf

Labels for NDA 210589

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210589s003lbl.pdf
05/08/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210589s001lbl.pdf
07/27/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/0210589s000lbledt.pdf

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